Recruiting

Radiotherapy & Immunotherapy

Sponsor:

Bo Lu

Code:

NCT06410300

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Curative Radiotherapy

Immunotherapy

Study Details

Brief summary:

The overall purpose of this study is to evaluate cardiopulmonary toxicity in patients with lung cancer (NSCLC or SCLC) undergoing combined thoracic radiotherapy ± chemotherapy and immunotherapy through timed monitoring and blood sample collection and to identify correlative biomarkers for predicting cardiopulmonary adverse events.

Conditions

Lung Cancer

Study ID

NCT06410300

Start date

Apr 19, 2024

Status verified date

Jul, 2026

Completion date

Apr 19, 2030

Anticipated

Primary completion date

Apr 19, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient older than 18 years age
  • Diagnosis of locally advanced lung cancer (NSCLC or SCLC) with planned curative radiotherapy (45Gy and above) and planned consolidation immunotherapy.

  • Patients who are not receiving concurrent chemotherapy and radiotherapy are eligible.
  • Patients on a clinical trial that includes thoracic radiotherapy and immunotherapy are eligible and may be co-enrolled to this study.
  • ECOG performance status of 0-2
  • Life expectancy of 6 months or longer
  • Patient able to provide a written informed consent prior to study entry

Exclusion Criteria:

  • Prior thoracic radiotherapy to chest.
  • Patients are excluded if they are not candidates for curative thoracic radiotherapy or immunotherapy.
  • Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Interventions

Curative Radiotherapy

Radiation dose of 45 Gy or higher

Immunotherapy

checkpoint inhibitor per PI discretion

Primary outcome measure

  • Clinical cardiopulmonary toxicities [ Time Frame: 25 months ]

Central Contacts and Locations

Central contacts

Brooke McDaniel

(573) 882-7440mcdanielbl@health.missouri.edu

Locations

University of Missouri - Ellis Fischel Cancer Center

Recruiting

Columbia, Missouri, United States, 65212

Principal Investigator:

Bo Lu, MD

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator:

Salma Jabbour, MD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Principal Investigator:

Yuhchyau Chen, MD, PhD

More Information

Sponsor

Bo Lu

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bo Lu on 2026-07-30.